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Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: Design and baseline characteristics of SOUL, a randomized trial
The rule says, in language unusual for its directness, that “supply issues, convenience and cost are not part of FDA’s clinical-need analysis for the 503B Bulks List.” The agency made the same point three more times in slightly different words
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